Latest Insights

Annex I

Annex 1 Quality & Compliance August 2022 Update

Annex 1 was finally released in August 2022. It is time to consider the impact of these requirements on your own enterprise and organization.

Annex I

Interview with Annex 1 Expert - Giovanna Cantoni

Watch the interview with PQE Group Annex 1 Expert Giovanna Cantoni

Annex I

New EU GMP Annex 1 & Sterility Assurance Barrier Technologies vs. Quality Management

Product contamination is one of the topics addressed in the new EU GMP Annex I, our expert Alessio Rosati explores the topic on our blog

Medical Device

FDA Software Guidance; Should I be worried?

FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?

CSV & Data Integrity

GAMP 5 Guide 2nd Edition Release

Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.

RA & PhV

Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards

RA & PhV

The EU Road to reach interoperability across regulatory systems: are you in step with the new EMA standards and regulatory systems?

The Life Science industry revolution goes along with the development of data interoperability systems that allow shared data within the entire.

GxP Compliance

Biotech Products and the Challenge of Next Generation Cleaning Strategies

Cleaning Validation for Biotech products: our expert Marco Paolillo addresses the main challenges in the process.

Medical Device

Israel MDSAP Affiliate Membership

The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?

GxP Compliance

What’s the “Cleaning Meaning”? The “5 Ws” of Cleaning Validation

Cleaning Validation in the Pharmaceutical Industry: our expert Marco Paolillo addresses the 5Wsv to avoid contamination and cross-contamination.